Esophageal stents

ABSTRACT

Methods for attaching a luminal device to the esophageal wall are described. In one embodiment, a method may include forming a bulge in an anchoring membrane of the luminal device and the esophageal wall, piercing the bulge from a first side of the anchoring membrane and a first side of the esophageal wall, placing a second retention element of a tissue anchor on a second side of the esophageal wall; and placing a tension element of the tissue anchor through the anchoring membrane and the esophageal wall. The tension element may be coupled to the second retention element. The method may further include placing a first retention element on the first side of the anchoring membrane. The first retention element may be coupled to the tension element.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/930,656, filed Nov. 2, 2015, which claims the benefit of U.S.provisional application Nos. 62/147,588, filed Apr. 15, 2015, and62/073,927, filed Oct. 31, 2014. The applications listed above arehereby incorporated by reference in their entireties.

BACKGROUND

Esophageal stents are used to treat strictures and malignances in theesophagus. Esophageal stents are also used to treat fistulas,perforations, and leaks in the esophagus.

An esophageal stent may be held in place by its own outward bias.However, the esophageal stent may migrate out of position, or migratecompletely out of the esophagus. An esophageal stent may be held inplace by tissue ingrowth portions which allow the esophageal wall togrow into the esophageal stent. However, the esophageal stentsubsequently becomes difficult to remove or reposition.

What is needed is an esophageal stent which reduces the likelihood ofmigrating out of position. What is needed is an esophageal stent whichreduces the likelihood of migrating out of position, and also allowssubsequent removal or repositioning.

SUMMARY

Luminal devices are described. In one embodiment, a luminal deviceincludes an esophageal stent and an anchoring membrane coupled to theesophageal stent. The anchoring membrane may be configured to be coupledto an esophageal wall with a tissue anchor placed through the anchoringmembrane. The anchoring membrane may be configured to be pierced toallow the tissue anchor to be placed through the anchoring membrane.

Methods for attaching a luminal device to the esophageal wall aredescribed. In one embodiment, a method may include forming a bulge in ananchoring membrane of the luminal device and the esophageal wall,piercing the bulge from a first side of the anchoring membrane and afirst side of the esophageal wall, placing a second retention element ofa tissue anchor on a second side of the esophageal wall; and placing atension element of the tissue anchor through the anchoring membrane andthe esophageal wall. The tension element may be coupled to the secondretention element. The method may further include placing a firstretention element on the first side of the anchoring membrane. The firstretention element may be coupled to the tension element.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows one embodiment of luminal device 1100. FIG. 1B showsanother embodiment of luminal device 1100.

FIGS. 2A-2C shows two embodiments of a tissue anchor 1300.

FIGS. 3A-3D show one embodiment of an anchor delivery device 1600.

FIGS. 4A-4J show one embodiment of a method for delivering a luminaldevice.

DESCRIPTION

FIG. 1A shows one embodiment of a luminal device 1100. FIG. 1B showsanother embodiment of luminal device 1100.

Luminal device 1100 may be configured to treat strictures, malignancies,fistulas, perforations, and leaks in the esophagus.

Luminal device 1100 may include an esophageal stent 1120.

Esophageal stent 1120 may be configured to be placed at least partiallyin the esophagus. Esophageal stent 1120 may be placed against theesophageal wall. Esophageal stent 1120 may be configured to be placedthrough a stricture or malignancy in the esophagus. Esophageal stent1120 may be configured to keep the esophagus at least partially openthrough a stricture or malignancy in the esophagus. Esophageal stent1120 may be configured to be placed against a fistula, perforation, orleak in the esophageal wall. Esophageal stent 1120 may be configured toreduce leakage from a fistula, perforation, or leak in the esophagealwall.

Esophageal stent 1120 may include a scaffold 1125. Scaffold 1125 mayinclude a proximal portion 1125 p, a middle portion 1125 m, and a distalportion 1125 d.

Scaffold 1125 may be configured to have an outward bias. Scaffold 1125may be configured to have an outward bias sufficient to keep theesophagus at least partially open through a stricture or malignancy inthe esophagus. Scaffold 1125 may have an outward bias sufficient to keepthe esophagus at least 10% open through the stricture or malignancy inthe esophagus.

Scaffold 1125 may have a width that is constant. Scaffold 1125 may havea width greater at proximal portion 1125 p and/or distal portion 1125 d.

Scaffold 1125 may include a braid 1126. Braid 1126 may be made ofplastic, metal, or other suitable material. Braid 1126 may have uniformor varying opening sizes. Scaffold 1125 may include a stent, a mesh, orother suitable structure.

Esophageal stent 1120 may include a liner 1121. Liner 1121 may becoupled to scaffold 1125. Liner 1121 may include two or more layers thatsandwich scaffold 1125, such as by blow molding. Liner 1121 may includea coating formed on scaffold 1125, such as by dip coating.

Liner 1121 may be configured to line the esophagus. Liner 1121 may beconfigured to be placed against a fistula, perforation, or leak in theesophageal wall. Liner 1121 may be configured to reduce leakage from afistula, perforation, or leak in the esophageal wall.

Liner 1121 may be made of silicone, polyethylene, polypropylene, apolyurethane such as PELLETHANE, or other suitable material.

Luminal device 1100 includes an anchor attachment element 1130.

Anchor attachment element 1130 may include at least one anchoringmembrane 1131. Anchoring membrane 1131 may include a first side 1131′and a second side 1131″. Anchoring membrane 1131 is coupled toesophageal stent 1120. Anchoring membrane 1131 may be coupled toproximal portion 1125 p, middle portion 1125 m, distal portion 1125 d,or any part of scaffold 1125. Anchoring membrane 1131 may interruptscaffold 1125 and/or liner 1121.

Anchoring membrane 1131 may be configured to be placed in the esophagus.Anchoring membrane 1131 may be configured to be placed next to a wall ofthe esophagus. Anchoring membrane 1131 may be configured to be attachedto a tissue anchor. Anchoring membrane 1131 may be configured to beattached to the wall of the esophagus with a tissue anchor placedthrough anchoring membrane 1131. Anchoring membrane 1131 may beconfigured to be pierced to allow a tissue anchor to be placed throughanchoring membrane 1131 and attach anchoring membrane 1131 to the wallof the esophagus. Anchoring membrane 1131 may be configured to retain atissue anchor placed through anchoring membrane 1131. Anchoring membrane1131 may be sufficiently strong to prevent a tissue anchor placedthrough anchoring membrane from pulling through and/or tearing anchoringmembrane 1131.

Anchoring membrane 1131 may be configured to be collapsible. Anchoringmembrane 1131 may be configured to be pulled or collapsed with a vacuumapplied to first side 1131′ of anchoring membrane 1131. Anchoringmembrane 1131 may be configured to be pulled or collapsed with a grasperor hook from first side 1131′ of anchoring membrane 1131. Anchoringmembrane 1131 may be configured to be pulled or collapsed toward firstside 1131′ of anchoring membrane 1131.

Anchoring membrane 1131 may be flexible. Anchoring membrane 1131 may bestretchable and recover without permanent set.

Anchoring membrane 1131 may include one or more layers. Anchoringmembrane 1131 may be made of silicone, polyethylene, polypropylene, apolyurethane such as PELLETHANE, or other suitable material.

Anchoring membrane 1131 may include one or more perforations 1132 formedin anchoring membrane 1131.

Perforations 1132 may be configured to allow at least a portion of avacuum applied to one side of anchoring membrane 1131 to reach throughanchoring membrane 1131. Perforations 1132 may be configured to allow atleast a portion of a vacuum applied to anchoring membrane 1131 to reacha tissue wall placed next to anchoring membrane 1131. Perforations 1132may be configured to allow at least a portion of a vacuum applied tofirst side 1131′ of anchoring membrane 1131 to reach a tissue wallplaced next to second side 1131″ of anchoring membrane 1131.

Perforations 1132 may include any one or any combination of holes,slits, and other openings of any suitable shape and size.

Anchoring membrane 1131 may include one or more pulls 1133. Pulls 1133may be coupled to anchoring membrane 1131 and/or reinforcement structure1135. Pulls 1133 may extend from first side 1131′ of anchoring membrane1131.

Pulls 1133 may be configured to allow anchoring membrane 1131 to bepulled or collapsed. Pulls 1133 may be configured to allow anchoringmembrane 1131 to be pulled or collapsed toward first side 1131′ ofanchoring membrane 1131.

Pulls 1133 may include any one or any combination of loops, tabs, andother suitable structures. Pulls 1133 may be made of a biodegradablematerial.

Anchoring membrane 1131 may include one or more creases 1134. Creases1134 may be formed by scoring anchoring membrane 1131 and/or formingthinner portions of anchoring membrane 1131. Creases 1134 may beconfigured to allow anchoring membrane 1131 to collapse along creases1134. Creases 1134 may allow anchoring membrane 1131 to be more easilyand/or predictably pulled or collapsed.

Anchor attachment element 1130 may include a reinforcement structure1135. Reinforcement structure 1135 may be coupled to anchoring membrane1131.

Reinforcement structure 1135 may be configured to reinforce anchoringmembrane 1131. Reinforcement structure 1135 may be configured to retaina tissue anchor placed through reinforcement structure 1135.Reinforcement structure 1135 may be configured to reduce the likelihoodof a tissue anchor placed through anchoring membrane 1131 pullingthrough and/or tearing anchoring membrane 1131.

Reinforcement structure 1135 may include a braid 1136. Braid 1136 mayhave uniform or varying opening sizes. Braid 1136 may be made ofplastic, metal, or other suitable material. Reinforcement structure 1135may include a stent, mesh, or other suitable structure.

Reinforcement structure 1135 may be coupled between two layers ofanchoring membrane 1131. Reinforcement structure 1135 may be coupledbetween two layers of anchoring membrane 1131 blow molded to sandwichreinforcement structure 1135. Reinforcement structure 1135 may provide asubstrate on which at least a portion of anchoring membrane 1131 isformed, such as by dip coating, spray coating, or other suitablemethods.

Reinforcement structure 1135 may include one or more creases 1137.Creases 1137 may be formed by scoring reinforcement structure 1135and/or forming thinner portions of reinforcement structure 1135. Creases1137 may be configured to allow reinforcement structure 1135 to collapsealong creases 1137. Creases 1137 may allow reinforcement structure 1135to be more easily and/or predictably pulled or collapsed.

Liner 1121 and anchoring membrane 1131 may have the same or differentproperties. Liner 1121 and anchoring membrane 1131 may be made of thesame or different materials and/or thicknesses.

Scaffold 1125 and reinforcement structure 1135 may have the same ordifferent properties. Scaffold 1125 and reinforcement structure 1135 maybe made of the same or different materials and/or thicknesses. Scaffold1125 may overlap with reinforcement structure 1135.

Any combination of liner 1121, anchoring membrane 1131, scaffold 1125,and reinforcement structure 1135 may be formed as one or more pieces.For example, anchoring membrane 1131 and reinforcement structure 1135may be formed as a single piece.

Esophageal stent 1120 and anchoring membrane 1131 may have the same ordifferent widths.

Esophageal stent 1120 may have a length of approximately 20 mm to 150mm. Anchoring membrane 1131 may have a length of approximately 10 mm to40 mm. Esophageal stent 1120 and anchoring membrane 1131 may have widthsof approximately 15 mm to 35 mm.

Luminal device 1100 may include one or more drawstrings 1152.Drawstrings 1152 may be coupled to esophageal stent 1120 and/oranchoring membrane 1131. Drawstrings 1152 may be at least partiallycoupled around esophageal stent 1120 and/or anchoring membrane 1131.Drawstrings 1152 may be configured to reduce a width of esophageal stent1120 and/or anchoring membrane 1131 for delivery and/or removal ofluminal device 1100. Drawstrings 1152 may be removable or non-removable.One or more drawstrings 1152 may include a loose portion forming a loop1152′ which may facilitate grasping drawstring 1152.

Luminal device 1100 may include at least one stiffening member 1154.Stiffening member 1154 may be coupled along at least a portion of alength of luminal device 1100. Stiffening member 1154 may be configuredto reduce the likelihood of esophageal stent 1120 and/or anchoringmembrane 1131 inverting. Stiffening member 1154 may be bonded toesophageal stent 1120 and/or anchoring membrane 1131. Stiffening member1154 may be elongate. Stiffening member 1154 be made of metal, plastic,or other suitable material. Stiffening member 1154 may be radiopaque.

Luminal device 1100 may include one or more radiopaque markers 1156.Radiopaque markers 1156 may be coupled to esophageal stent 1120 and/oranchoring membrane 1131. Radiopaque markers 1156 may be configured tofacilitate delivery of luminal device 1100.

Luminal device 1100 may include one or more tissue ingrowth elements1180. Tissue ingrowth elements 1180 may be configured to allow theesophageal wall to grow into esophageal stent 1120 and/or anchoringmembrane 1131.

Tissue ingrowth elements 1180 may include one or more holes 1181 formedin esophageal stent 1120 and/or anchoring membrane 1131. Holes 1181 maybe configured to allow tissue ingrowth. Tissue ingrowth elements 1180may include exposed portions of scaffold 1125. Tissue ingrowth elements1180 may include exposed portions of reinforcement structure 1135.

Luminal device 1100 may include a tissue anchor 1300. Luminal device1100 may include any of the tissue anchors described in U.S. patentapplication Ser. Nos. 14/930,652 and 14/930,655, filed Nov. 2, 2015, andU.S. patent application publication nos. 2009/0012541 and 2015/0018745,each of which are incorporated by reference.

FIGS. 2A-2C show embodiments of a tissue anchor 1300. FIGS. 2A-2B showperspective and side views, respectively, of one embodiment of tissueanchor 1300. FIG. 2C shows another embodiment of tissue anchor 1300.

Tissue anchor 1300 may be configured to attach a device to a tissuewall. Tissue anchor 1300 may be configured to attach a luminal device tothe esophageal wall.

Tissue anchor 1300 may include a first retention element 1310. Firstretention element 1310 may be configured to be placed on a first side ofan anchoring membrane of a luminal device. First retention element 1310may be configured to be placed on a proximal side of an anchoringmembrane of a luminal device.

First retention element 1310 may include a T-tag 1311. T-tag 1311 mayinclude a longitudinal cylindrical segment, such as one-third orone-fourth of a cylindrical tube cut lengthwise. T-tag 1311 may beconfigured to fit between the outside of a delivery needle and an insideof a catheter lumen. T-tag 1311 may be configured to fit in a gapbetween a delivery needle and a catheter lumen. T-tag 1311 may include apull 1312 to facilitate removal. First retention element 1310 mayinclude a button or other suitable device.

Tissue anchor 1300 includes a second retention element 1320. Secondretention element 1320 may be configured to be placed on a second sideof a tissue wall. Second retention element 1320 may be configured to beplaced on a distal side of a tissue wall.

Second retention element 1320 may include a hub 1323. Hub 1323 mayinclude a proximal portion 1323 p, a distal portion 1323 d, and alongitudinal axis 1323 a.

Second retention element 1320 may include one or more petals 1324.Petals 1324 may be coupled to hub 1323. Petals 1324 may extend fromdistal portion 1323 d of hub 1323. Petals 1324 may be configured to becollapsed inside a delivery needle. Petals 1324 may be coupled to hub1323 by being at least partially inserted into opening 1324. Petals 1324may be coupled to hub 1323 with any one or any combination of anadhesive, solder, weld, compression fit, and other suitable methods.Petals 1324 may be formed of lengths of wire. Hub 1323 and petals 1324may be formed as one or more pieces.

Petals 1324 may include a contact portion 1325. Contact portion 1325 maybe configured to be substantially perpendicular to longitudinal axis1323 a of hub 1323. Contact portion 1325 may be configured to beproximal to proximal portion 1323 p of hub 1323.

Alternatively, second retention element 1320 may include a T-tag 1321,as shown in FIG. 2C. T-tag 1321 may be configured to be loaded in adelivery needle. Second retention element 1320 may include any of theretention elements described in U.S. patent application Ser. Nos.14/930,652 and 14/930,655, filed Nov. 2, 2015, and U.S. patentapplication publication nos. 2009/0012541 and 2015/0018745, each ofwhich are incorporated by reference.

Tissue anchor 1300 includes a tension element 1350. Tension element 1350may be configured to couple first retention element 1310 and secondretention element 1320. Tension element 1350 may be configured to placedthrough an anchoring membrane and a tissue wall.

Tension element 1350 may include a suture 1351. Suture 1351 may have aproximal portion 1351 p and a distal portion 1351 d. Proximal portion1351 p of suture 1351 may be coupled to first retention element 1310.Proximal portion 1351 p of suture 1351 may be coupled to T-tag 1311,such as with an adhesive and/or a knot. Distal portion 1351 d of suture1351 may be coupled to second retention element 1320. Distal portion1351 d of suture 1351 may be coupled to hub 1323 of second retentionelement 1320. Tension element 1350 may include a wire, a stent, or othersuitable device. Tension element 1350 may be made of a polymer or othersuitable material.

Alternatively, tissue anchor 1300 may include no first retention element1310, and proximal portion 1351 p of suture 1351 may be coupled to aluminal device.

FIGS. 3A-3D show one embodiment of an anchor delivery device 1600. FIG.3A shows a perspective view of anchor delivery device 1600. FIG. 3Bshows an enlarged view of an anchoring cavity 1630 of anchor deliverydevice 1600. FIG. 3C shows an enlarged view of a delivery needle 1660.FIG. 3D shows a cross-sectional view of delivery needle 1660. FIGS.3C-3D show delivery needle 1660 loaded with a tissue anchor 1300. FIGS.3C-3D show delivery needle 1660 advanced out of a secondary lumen 1622of a catheter 1620.

Anchor delivery device 1600 may be configured to place tissue anchorsthrough a device and a tissue wall. Anchor delivery device 1600 may beconfigured to place tissue anchors through an esophageal stent and anesophageal wall.

Anchor delivery device 1600 may include a catheter 1620. Catheter 1620may include a proximal portion 1620 p, a distal portion 1620 d, and alongitudinal axis 1620 a.

Catheter 1620 may include a primary lumen 1621. Primary lumen 1621 maybe configured to accommodate an endoscope or other instrument.

Catheter 1620 may include at least one secondary lumen 1622. Secondarylumen 1622 may be formed in a wall of catheter 1620. Secondary lumen1622 may include a proximal portion 1622 p and a distal portion 1622 d.Secondary lumen 1622 may be configured to accommodate a delivery needle.

Distal portion 1622 d of secondary lumen 1622 may be angled and/orcurved inward toward longitudinal axis 1620 a of catheter 1620. Distalportion 1622 d of secondary lumen 1622 may be angled and/or curvedinward toward longitudinal axis 1620 a from approximately 0 degrees to10 degrees.

Catheter 1620 may have a width of approximately 10 mm to 20 mm.

Anchor delivery device 1600 may include an anchoring cavity 1630 formedin catheter 1620. Anchoring cavity 1630 may include a proximal side 1630p and a distal side 1630 d. Anchoring cavity 1630 may be at or neardistal portion 1620 d of catheter 1620. Anchoring cavity 1630 may beproximal to tip 1626. Anchoring cavity 1630 may be in communication withprimary lumen 1621 and secondary lumen 1622.

Anchoring cavity 1630 may be configured to draw in a portion of ananchoring membrane. Anchoring cavity 1630 may be configured to draw in aportion of an anchoring membrane and a tissue wall.

Anchoring cavity 1630 may cut completely through distal portion 1622 dof secondary lumen 1622. Distal portion 1622 d of secondary lumen 1622may be positioned at a proximal side 1630 p of anchoring cavity 1630.

Anchoring cavity 1630 may have a length of approximately 10 mm to 40 mm.Anchoring cavity 1630 may have a width of approximately 10 mm to 20 mm.

Anchor delivery device 1600 may include a delivery needle 1660. Deliveryneedle 1660 may include a proximal portion 1660 p and a distal portion1660 d. Delivery needle 1660 may be slidably disposed within secondarylumen 1622. Delivery needle 1660 may be configured to be advanced out ofand withdrawn into secondary lumen 1622.

Delivery needle 1660 may include a needle lumen 1661. Needle lumen 1661may be configured to be loaded with a second retention element of atissue anchor in a collapsed or delivery configuration. Needle lumen1661 may also be configured to be loaded with a first retention elementand/or a second retention element of a tissue anchor in a collapsed ordelivery configuration. Needle lumen 1661 may also be configured to beloaded with a therapeutic agent. Therapeutic agent may include any oneor any combination of a phospholipid gel, hyaluronic acid, and otheragents.

Delivery needle 1660 may include a tip 1668. Tip 1668 may be coupled todistal portion 1660 d of delivery needle 1660. Tip 1668 may beconfigured to pierce an anchoring membrane. Tip 1668 may be configuredto pierce a tissue wall. Tip 1668 may be sharp.

Delivery needle 1660 may include a slot 1669. Slot 1669 may be formedlongitudinally at distal portion 1660 d of delivery needle 1660. Slot1669 may be configured to allow a tension element of a tissue anchor topass through so that a second retention element of a tissue anchor maybe loaded inside of needle lumen 1661 and a first retention element of atissue element may be loaded outside of needle lumen 1661.

Distal portion 1660 d of delivery needle 1660 may be angled and/orcurved inward toward longitudinal axis 1620 a of catheter 1620. Distalportion 1660 d of delivery needle 1660 may be angled and/or curvedinward toward longitudinal axis 1620 a from approximately 0 degrees to10 degrees. This may reduce the likelihood of contacting bodily parts onthe other side of a tissue wall.

Delivery needle 1660 and secondary lumen 1622 may be configured todefine a gap 1623 when delivery needle 1660 is slidably disposed withinsecondary lumen 1622. Delivery needle 1660 and secondary lumen 1622 mayhave sizes selected to define a gap 1623 when delivery needle 1660 isslidably disposed within secondary lumen 1622. Gap 1623 may beconfigured to be loaded with a proximal delivery element of a tissueanchor. Gap 1623 may be configured to be loaded with a proximal deliveryelement such as a T-tag that is thin and elongate. Gap 1623 may beconfigured to be loaded with proximal delivery element such as a T-tagsuch as T-tag 1311 of tissue anchor 1300.

Anchor delivery device 1600 may include a pushrod 1670. Pushrod 1670 mayinclude a proximal portion 1670 p and a distal portion 1670 d. Pushrod1670 may be slidably disposed within needle lumen 1661.

Pushrod 1670 may be configured to push a second retention element of atissue anchor out of needle lumen 1661 of delivery needle 1660. Pushrod1670 may be configured to push a first retention element of a tissueanchor out of needle lumen 1661.

Pushrod 1670 may include a channel 1679. Channel 1679 may be formedlongitudinally at distal portion 1670 d of pushrod 1670. Channel 1679may be configured to allow a tension element of a tissue anchor to passthrough. Channel 1679 may be aligned with slot 1669 of delivery needle1660.

FIGS. 4A-4J show one embodiment of a method for delivering a luminaldevice. Although delivery of luminal device 1000 is shown as an example,the method may also be used to deliver other luminal devices andesophageal stents.

FIG. 4A shows loading luminal device 1100 onto anchor delivery device1600. Distal portion 1620 d of catheter 1620 is inserted into the lumenof luminal device 1100.

FIG. 4B shows coupling luminal device 1100 to anchor delivery device1600. Drawstring 1152 may be cinched to couple luminal device 1100 toanchor delivery device 1600.

FIG. 4C shows positioning luminal device 1100 at an attachment point.Catheter 1620 is advanced into the esophagus E to position anchoringmembrane 1131 of luminal device 1100 in the esophagus E. An endoscopemay be used in primary lumen 1621 to guide catheter 1620. A tether T maybe used to adjust the position of luminal device 1100 and/or controldrawstring 1152. Tissue marks made previously by tissue marking device1400 may be used as a guide.

FIG. 4D shows releasing luminal device 1100 from anchor delivery device1600. Drawstring 1152 may be uncinched to release luminal device 1100from anchor delivery device 1600.

FIG. 4E shows positioning anchoring cavity 1630 of anchor deliverydevice 1600 next to anchoring membrane 1131 and the tissue wall W.

FIG. 4F shows forming a bulge 1130 b in anchoring membrane 1131 and thetissue wall W. Delivery needle 1660 is retracted completely withinsecondary lumen 1622. A vacuum may be applied to anchoring cavity 1630to draw anchoring membrane 1131 and the tissue wall W into anchoringcavity 1630 to form bulge 1130 b. The vacuum may be approximately 50mmHg to 500 mmHg.

Alternatively, anchoring membrane 1131 and tissue wall W may be pulledinto anchoring cavity 1630 by a grasper or other suitable device to formbulge 1130 b. Alternatively, anchoring membrane 1131 and the tissue wallW may be allowed to enter anchoring cavity 1630 without assistance, suchas from muscle activity of the tissue wall W, to form bulge 1130 b.

FIG. 4G shows piercing bulge 1130 b from first a side 1131′ of anchoringmembrane 1131 and a first side W′ of the tissue wall W. Delivery needle1660 may be advanced a set distance out of secondary lumen 1622 ofcatheter 1620. Delivery needle 1660 may be advanced through bulge 1130 bto position tip 1668 of delivery needle 1660 on a second side W″ of thetissue wall W.

Delivery needle 1660 may be advanced in a direction substantiallyparallel to longitudinal axis 1620 a of catheter. Delivery needle 1660may be advanced in a direction substantially parallel to the tissue wallW other than bulge 1130 b. Delivery needle 1660 may be advanced in adirection approximately 0 degrees to 10 degrees from parallel towardlongitudinal axis 1620 a of catheter. Delivery needle 1660 may beadvanced in a direction approximately 0 degrees to 10 degrees fromparallel away from the tissue wall W other than bulge 1130 b.

FIG. 4H shows placing second retention element 1320 of tissue anchor1300 on a second side W″ of the tissue wall W. Delivery needle 1660 maybe pulled back over pushrod 1670 to release second retention element1320 from needle lumen 1661. Alternatively, pushrod 1670 may be advanceda set distance through delivery needle 1660 to release second retentionelement 1320 from needle lumen 1661. A therapeutic agent may also bereleased from needle lumen 1661. Second retention element 1320 expands.

FIG. 4I shows placing tension element 1350 of tissue anchor 1300 throughanchoring membrane 1131 and the tissue wall W. Delivery needle 1660 andpushrod 1670 may be pulled back through the tissue wall W and pulledback through anchoring membrane 1131 to place tension element 1350through the tissue wall W and anchoring membrane 1131.

FIG. 4J shows placing first retention element 1310 of tissue anchor 1300on first side 1131′ of anchoring membrane 1131. Bulge 1130 b may bereleased. Vacuum applied to anchoring cavity 1630 may be stopped. Firstretention element 1310 is placed on first side 1131′ of anchoringmembrane 1131. First retention element 1310 may be pulled out ofsecondary lumen 1622 of catheter 1620 by tension element 1350.

Alternatively, delivery needle 1660 may be advanced through bulge 1130 bat both proximal side 1630 p and distal side 1630 d of anchoring cavity1630, to position tip 1668 of delivery needle 1660 back on first side1131′ of anchoring membrane 1131. Second retention element 1320 may beplaced on first side 1131′ of anchoring membrane 1131, tension element1350 may be placed through anchoring membrane 1131 and the tissue wall Wat two points, and first retention element 1310 may also be placed onfirst side 1131′ of anchoring membrane 1131.

Alternatively, delivery needle 1660 may be advanced only partiallythrough bulge 1130 b at proximal side 1630 p of anchoring cavity 1630.Delivery needle 1660 may be advanced through anchoring membrane 1131 andonly partially through the tissue wall W, to position tip 1668 ofdelivery needle 1660 within the tissue wall W, such as between layers ofthe tissue wall W. Second retention element 1320 may be placed withinthe tissue wall W, tension element 1350 may be placed through anchoringmembrane 1131 and part of the thickness of tissue wall W, and firstretention element 1310 may be placed on first side 1131′ of anchoringmembrane 1131.

Anchor delivery device 1600 may be rotated within luminal device 1100 todeliver one or more additional tissue anchors. Delivery needle 1660 maybe removed from secondary lumen 1622 to be reloaded with another tissueanchor, or exchanged for another delivery needle 1660 that has alreadybeen loaded.

While the foregoing has been with reference to particular embodiments ofthe invention, it will be appreciated by those skilled in the art thatchanges in these embodiments may be made without departing from theprinciples and spirit of the invention.

What is claimed is:
 1. A luminal device, comprising: an esophagealstent; and an anchoring membrane coupled to the esophageal stent, theanchoring membrane configured to be attached to an esophageal wall witha tissue anchor placed through the anchoring membrane.
 2. The luminaldevice of claim 1, wherein the anchoring membrane is configured to bepierced to allow the tissue anchor to be placed through the anchoringmembrane.
 3. The luminal device of claim 1, wherein the anchoringmembrane is configured to retain a tissue anchor placed through theanchoring membrane.
 4. The luminal device of claim 1, furthercomprising: a braid coupled to the anchoring membrane, the braidconfigured to reinforce the anchoring membrane.
 5. The luminal device ofclaim 1, wherein the anchoring membrane is collapsible.
 6. The luminaldevice of claim 1, further comprising: one or more perforations formedin the anchoring membrane, the perforations configured to allow a vacuumto reach through the anchoring membrane.
 7. The luminal device of claim1, further comprising: one or more pulls coupled to the anchoringmembrane, the pulls configured to allow the anchoring membrane to bepulled.
 8. The luminal device of claim 1, further comprising: one ormore creases formed in the anchoring membrane, the creases configured toallow the anchoring membrane to collapse along the creases.
 9. A luminaldevice, comprising: an esophageal stent; and an anchor retaining meanscoupled to the esophageal stent, the anchor attachment means configuredto be attached to a wall of an esophagus with a tissue anchor placedthrough the anchor retaining means.
 10. The luminal device of claim 9,further comprising: a reinforcement means coupled to the anchorretaining means, the reinforcement means configured to reinforce theanchor retaining means.
 11. A method for attaching a luminal device toan esophageal wall, the method comprising: forming a bulge in ananchoring membrane of the luminal device and the esophageal wall;piercing the bulge from a first side of the anchoring membrane and afirst side of the esophageal wall; placing a second retention element ofa tissue anchor on a second side of the esophageal wall; and placing atension element of the tissue anchor through the anchoring membrane andthe esophageal wall, the tension element coupled to the second retentionelement.
 12. The method of claim 11, wherein forming a bulge includesdrawing the anchoring membrane and the esophageal wall with a vacuum.13. The method of claim 11, wherein forming a bulge includes pulling theanchoring membrane and the esophageal wall with a grasper.
 14. Themethod of claim 11, wherein piercing the bulge includes advancing adelivery needle through the bulge to position a tip of the deliveryneedle on a second side of the esophageal wall.
 15. The method of claim14, wherein advancing a delivery needle includes advancing a deliveryneedle in a direction between 0 degrees and 10 degrees from parallel tothe esophageal wall other than the bulge.
 16. The method of claim 11,wherein placing a second retention element includes pushing the secondretention element out of a lumen of the delivery needle.
 17. The methodof claim 16, wherein placing a tension element includes pulling thedelivery needle back through the bulge.
 18. The method of claim 11,further comprising: placing a first retention element on the first sideof the anchoring membrane, the first retention element coupled to thetension element.